Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000225-51
    Sponsor's Protocol Code Number:ITP-NODAT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-000225-51
    A.3Full title of the trial
    Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients
    ENSAYO CLINICO ALEATORIZADO COMPARATIVO ENTRE EL USO PRECOZ DE INSULINA VERSUS EL TRATAMIENTO ESTÁNDAR EN PACIENTES CON HIPERGLUCEMIA DESPUES DE UN TRASPLANTE RENAL DE NOVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    ITP-NODAT
    ITP-NODAT
    A.4.1Sponsor's protocol code numberITP-NODAT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundació Institut Mar d'investigacions Mediques
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Diabetes, Digestive and Kidney Disease (NIDDK)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Institut Mar d'investigacions Mediques
    B.5.2Functional name of contact pointAnna Faura
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim 25-29. Edifici Hospital del mar
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932483689
    B.5.5Fax number0034932483373
    B.5.6E-mailafaura@parcdesalut.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Humulin NPH
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namehuman insulin isophane
    D.3.2Product code 656801.9
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN ISOPHANE
    D.3.9.1CAS number 53027-39-7
    D.3.9.3Other descriptive nameINSULIN ISOPHANE
    D.3.9.4EV Substance CodeSUB02793MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.
    Pacientes no diabeticos con enfermedad renal en fase terminal, sometidos a un trasplante renal
    E.1.1.1Medical condition in easily understood language
    Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.
    Pacientes no diabeticos con enfermedad renal en fase terminal, sometidos a un trasplante renal
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study aims to assess the effects of early insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.
    Este estudio pretende valorar los efectos de una terapia insulínica precoz en pacientes no-diabéticos trasplantados de novo de riñon, reduciendo la incidencia de la diabetes de novo en particular y el metabolismo alterado de la glucosa en general durante el subsiguiente seguimiento.
    E.2.2Secondary objectives of the trial
    1. To determine the improvement in overall glycemic control among patients managed with the early initiation of insulin therapy compared to standard of care management in patients experiencing abnormal glucose metabolism.
    2. To determine the improvement in β-cell function among patients assigned to the early initiation of insulin therapy compared to the standard of care management in patients experiencing abnormal glucose metabolism.
    1.Determinar la mejoría del control glicémico entre los pacientes tratados con terapia insulínica de inicio precoz comparados con el estándar de cuidado en pacientes que sufren un metabolismo de glucosa alterado.

    2.Determinar la mejoría en la función de las células β entre los pacientes a los que se les inicia una terapia insulínica precoz comparados con el estándar de cuidado en pacientes que sufren un metabolismo de glucosa alterado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
    2. Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose < 126 mg/dl).
    3. Receiving standard triple immunosuppressive medications that include tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids.
    4. Capable of understanding the study and willing to give informed written consent for study participation.
    1. Pacientes adultos con enfermedad renal en fase final sometidos a trasplante de riñón de vivo o cadáver.
    2. Ausencia de diabetes anterior al trasplante, definida según los criterios de la Asociación Americana de Diabetes (sin agentes hipoglicemiantes ni insulina en ayunas con glucosa < 126 mg/dl).
    3. Recibir la medicación de inmunosupresión triple estándar, que incluye tacrolimus, micofenolato mofetil o sódico y esteroides.
    4. Que sea capaz de entender el estudio y esté dispuesto a dar consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    1. Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart.
    2 Patients receiving an organ transplant other than kidney.
    3. Patients receiving an unlicensed drug or therapy within one month prior to study entry.
    4. Patients with history of hypersensitivity to injectable insulin.
    5. Patients with documented HIV infection.
    1. Pacientes con diagnóstico de diabetes mellitus previo al trasplante de riñón o que reciban antidiabéticos o que tengan unos niveles pretrasplante de glucosa en ayunas iguales o superiores a 126mg/dl en dos ocasiones con tres días de diferencia como mínimo.
    2. Pacientes que hayan recibido un órgano además del riñón.
    3. Pacientes que hayan recibido medicamentos o terapia en fase de investigación en el plazo de 1 mes antes del inicio del estudio.
    4. Pacientes con historial de hipersensibilidad a la insulina inyectable.
    5. Pacientes con infección de VIH documentada.

    E.5 End points
    E.5.1Primary end point(s)
    The incidence of NODAT 12 months after kidney transplantation defined according to American Diabetes Association criteria.
    La incidencia de NODAT 12 meses después del trasplante de riñón según los criterios de la Asociación Americana de Diabetes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Months
    12 meses
    E.5.2Secondary end point(s)
    1. The incidence of NODAT at 24 months after kidney transplantation.
    2. Glycemia profile during the time of insulin therapy in arm A (intervention) comparing that of arm B (control).
    3. The glycemia control using A1c levels, overall and among patients with NODAT, through study period 6, 12 and 24 months after kidney transplantation.
    4. Incidence of impaired fasting glycemia and impaired glucose tolerance 6, 12 and 24 months after transplantation.
    5. Pancreatic beta-cell function at 6, 12 and 24 months after kidney transplantation, measured as insulin secretion during an OGTT in relation to the glucose stimulation (insulinogenic index total and early phase).
    6. Fasting insulin resistance (mostly liver) at 6, 12 and 24 months after kidney transplantation, measured by HOMA-R and by QUICKI (insulin sensitivity) from fasting (basal) glucose and insulin concentration.
    7. Dynamic insulin sensitivity (mostly muscle and adipose tissues) at 6, 12 and 24 months after kidney transplantation, measured by OGIS and ISIcomp from OGTT data.
    8. Renal function at 6, 12 and 24 months after kidney transplantation, measured by serum creatinine.
    9 Patient and graft survival 6, 12 and 24 months after kidney transplantation.
    1. La incidencia de NODAT 24 meses después del trasplante de riñón según los criterios de la Asociación Americana de Diabetes.
    2. Perfil glicémico durante el tiempo de terapia insulínica en el brazo A (intervención) comparado con el del brazo B (control).
    3. El control de glicemia usando niveles A1c, en general y en los pacientes con NODAT, durante los periodos de estudio a los 6, 12 y 24 meses después del trasplante de riñón.
    4. Incidencia de glicemia basal alterada y test de tolerancia oral a la glucosa (TTOG) patológico a los 6, 12 y 24 meses después del trasplante.
    5. Función de la célula Beta pancreática a los 6, 12 y 24 meses post-trasplante de riñón, medido por la secreción de insulina durante un TTOG (Índice insulogenico total y en fase precoz).
    6. Resistencia a la insulina en ayunas (sobre todo en hígado) a los 6, 12 y 24 meses post-trasplante de riñón, medido con HOMA-R y con QUICKI (sensibilidad a la insulina) desde la glucosa en ayunas (basal) y concentración de insulina.
    7. Sensibilidad a la insulina principalmente los tejidos muscular y adiposo) a los 6, 12 y 24 meses post-trasplante de riñón, medido con OGIS y ISIcomp de los datos TTOG.
    8. Función renal a los 6, 12 y 24 meses post-trasplante, medido con creatinina sérica.
    9. Supervivencia del paciente y del injerto a los 6,12 y 24 meses post-trasplante renal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 24 months
    Pasados 24 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamiento estandard
    Standard treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Germany
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The completion of study is 24 months after the kidney transplantation.
    El final del ensayo será 24 meses después del trasplante de riñon.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 380
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 380
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    THE SAME AS THE NORMAL EXPECTED TREATEMENT OF THAT CONDITION
    EL MISMO QUE EL NORMAL EXPERADO PARA ESTA PATOLOGIA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 13:05:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA